CLEARASIL ULTRA OVERNIGHT FACE- salicylic acid lotion

Clearasil Ultra by

Drug Labeling and Warnings

Clearasil Ultra by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

Salicyclic acid 2%

Purpose

Acne Medication

Use

for the treatment of acne

Warnings

For external use only

When using this product

• Avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water
• With other topical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one acne medication should be used unless directed by your doctor
• Limit use to the face and neck

Stop use and ask a doctor if skin or eye irritation develops.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• Cleanse the skin thoroughly before applying medication
• Cover the entire affected area with a thin layer one to three times daily
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 applications daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

• Store in a cool, dry place
• Keep outer packaging for precautions and directions

Inactive ingredients

Water, Butylene Glycol, Octyldodecanol, Steareth-2, Cetyl Alcohol, Steareth-21, Dimethicone, Polyacrylamide Glycerin, C13-14 Isoparaffin, Phenoxyethanol, Sodium Hydroxide, Xanthan Gum, Magnesium Aluminum Silicate, Laureth-7, Fragrance, Lavandula Stoechas Extract, Helichrysum Italicum Extract, Cistus Monspeliensis Extract, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben, Titanium Dioxide

Questions?

Call 1-866-25-CLEAR (1-866-252-5327).

You may also report side effects to this phone number.

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Distributed by: Reckitt Benckiser LLC
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 38.4 mL Tube Carton

Clearasil®

ULTRA®

Overnight
Face Lotion

Salicylic Acid 2% Acne Medication

Helps
visibly reduce
pimple size
and redness
overnight

1.3 FL. OZ. (38.4 mL)

INGREDIENTS AND APPEARANCE

CLEARASIL ULTRA   OVERNIGHT FACE
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-339
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Octyldodecanol (UNII: 461N1O614Y)
Steareth-2 (UNII: V56DFE46J5)
Cetyl Alcohol (UNII: 936JST6JCN)
Steareth-21 (UNII: 53J3F32P58)
Dimethicone (UNII: 92RU3N3Y1O)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Hydroxide (UNII: 55X04QC32I)
Xanthan Gum (UNII: TTV12P4NEE)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Laureth-7 (UNII: Z95S6G8201)
Lavandula Stoechas Flowering Top (UNII: 70759G2U6A)
Helichrysum Italicum Flower Oil (UNII: O97ZV7726K)
Methylparaben (UNII: A2I8C7HI9T)
Butylparaben (UNII: 3QPI1U3FV8)
Ethylparaben (UNII: 14255EXE39)
Isobutylparaben (UNII: 0QQJ25X58G)
Propylparaben (UNII: Z8IX2SC1OH)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-339-01	38.4 mL in 1 TUBE; Type 0: Not a Combination Product	08/18/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	08/18/2011

Labeler - RB Health (US) LLC (081049410)